AU691245B2 - Wound dressing - Google Patents

Wound dressing Download PDF

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Publication number
AU691245B2
AU691245B2 AU16673/95A AU1667395A AU691245B2 AU 691245 B2 AU691245 B2 AU 691245B2 AU 16673/95 A AU16673/95 A AU 16673/95A AU 1667395 A AU1667395 A AU 1667395A AU 691245 B2 AU691245 B2 AU 691245B2
Authority
AU
Australia
Prior art keywords
fibres
weight
document
wound dressing
gb
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
AU16673/95A
Other versions
AU1667395A (en
Inventor
Michael James Lydon
Douglas Queen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ConvaTec Technologies Inc
Original Assignee
Bristol Myers Squibb Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to GB9400994A priority Critical patent/GB9400994D0/en
Priority to GB9400994 priority
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Priority to PCT/GB1995/000114 priority patent/WO1995019795A1/en
Publication of AU1667395A publication Critical patent/AU1667395A/en
Application granted granted Critical
Publication of AU691245B2 publication Critical patent/AU691245B2/en
Assigned to CONVATEC TECHNOLOGIES INC. reassignment CONVATEC TECHNOLOGIES INC. Alteration of Name(s) in Register under S187 Assignors: BRISTOL-MYERS SQUIBB COMPANY
Anticipated expiration legal-status Critical
Application status is Expired legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/60Liquid-swellable gel-forming materials, e.g. super-absorbents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225Mixtures of macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives

Description

WO 95/19795 PCT/GB95/00114 1 WOUND DRESSING This invention relates a would dressing and in particular a non-adherent wound dressing comprising fibrous material.

The invention also relates to a method of treating a wound comprising applying the dressing to a wound.

It is well known that the cleansing and debriding of wounds and the removal of wound exudate is important to the process of healing wounds. Commonly used wound dressings comprise gauze, foams, sponges, cotton wads or other fibrous materials. Gauze and other fibrous materials absorb fluids by capillary action with the disadvantage that when new tissue is formed as part of the healing process, it engulfs the fibres and is torn when the material is removed causing wound injury.

There thus exists a need for a dressing which is nonadherent while being absorbent.

It is known in the art to make absorbent fibres which are capable of forming a gel on contact with water. Such fibres tend to be rather expensive and the cost of a gauze or bandage made solely from such gel forming fibres prohibitive for some wound care applications.

We have nc, found that it is possible to make a wound dressing comprising a mixture of textile fibres and gel forming fibres which mitigates che disadvantages mentioned above.

Accordingly the present invention provides a wound dressing comprising in sheet form a mixture of textile fibres and gel forming fibres.

The wound dressing according to the invention may have the WO 95/19795 PCT/GB95/00114 2 advantages that it is non-adherent to wound tissue while being absorbent and relatively inexpensive and the added advantage that it may be retained on the wound for longer periods of time than conventional cotton gauze. This results in fewer changes of the dressing being needed which reduces material costs and health care personnel time. In addition a moist wound environment may be created which has been found to be beneficial to wound healing.

The dressing prefera I comprises from 50% to 95% by weight of textile fibres and from 5% to 50% by weight of gel forming fibres. More preferably the dressing comprises from 75% to 90% by weight of textile fibres and particularly 8u. by weight and from 10% to 25% of gel forming fibres and more particularly 20% by weight.

The textile fibres for use in the present invention can be natural or synthetic but are preferably cellulosic fibres for example viscose rayon, multi-limbed viscose, cotton, or regenerated cellulose or fibres having a higher absorbency than most textile fibres such as the multi-limbed cellulose fibres as described in EP-A-301874. In general textile fibres absorb liquids by capillary action and are not hygroscopic this means that their absorbancies as measured by the free swell absorbancy test are low such as less than 1 gram of liquid per gram of fibre.

The gel forming fibres for use in the present invention are hygroscopic fibres which upon the uptake of wound exudate become moist and slippery or gelatinous and thus reduce the tendancy for the surrounding fibres to adhere to the wound.

The gel forming fibres can be of the type which retain their structural integrity on absorbtion of exudate or can be of the type which lose their fibrous form and become a structureless gel or a solution on absorbtion of exudate.

The gel forming fibres are preferably spun sodium carboxymethylcellulose fibres, chemically modified WO 95/19795 PCT/GB95/00114 3 cellulosic fibres, in particular carboxymethylated cellulose fibres as described in PCT WO/9312275, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums. The cellulosic fibres preferably have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit. The gel forming fibres preferably have an absorbency of at least 2 grams 0.9% saline solution per gram of fibre (as measured by the free swell method) and a tenacity of at least 10cN/tex. The production of solventspun cellulose fibres is described for example in US-A- 4246221 and US-A-4196281 as well as in PCT WO/9312275 mentioned above. The alginate fibres are preferably of the highly absorbent type as described in WO 9417227 and WO 9400164.

Preferably the gel forming fibres for use in the present invention have an absorbency of at least 15 g/g as measured in the free swell absorbency method, more preferably between 25 g/g and 50 g/g. The degree of substitution of the cellulosic gel forming fibre is preferably at least 0.2 carboxymethyl groups per glucose unit, more preferably between 0.3 and 0.5. The tenacity of the fibre is preferably in the range 25-15 cN/tex.

The gel forming fibres suitable for use in the present invention can be processed using conventional textile machinery, for example by the staple route including cutting, carding and if desired crimping, drafting and spinning.

The wound dressing of the present invention is in sheet form and may be made by intimately mixing the gel forming fibres with the textile fibres, for example by carding or air-laying the fibres together to form a web of mixed fibres. Alternatively the wound dressing of the present invention may be made by spinning or twisting the gel I, WO 95/19795 PCT/GB95/00114 4 forming fibres and the textile fibres together to form a yarn and then knitting or weaving the yarn to form a bandage or stocking. The wound dressing of the present invention may be in the form of swabs, wound pads, wadding ribbons, sponges, nets and bandages and may be used as a primary or secondary dressing especially in the treatment of leg ulcers.

Various optional ingredients can also be included in the final composition such as preservatives and small amounts of pharmacologically active ingredients. For example an antibiotic or antimicrobial agent such as metronidazole, silver sulphadiazine, neomycin or penicillin and antiseptic agent such as povidone iodine and antiinflammatory agent such as hydrocortisone or triamcinolone acteonide or a skin protective agent such as a zinc oxide can be included.

The invention is illustrated by the following examples:- Example 1 Gel forming fibres were made as follows: A tow of 1.7 decitex solvent-spun cellulosic fibres, the fibres having a substantially uniform structure across their cross-section, as sold under the Trade Mark "Tencel" was obtained in a never-dried state. The tow was passed through a hand mangle. The amount of water left on the tow after mangling was 62%. This wet tow was placed in a solution containing 7.5% sodium hydroxide and 22.1% sodium monochloroacetate at room temperature for 2 minutes. The padded tow was mangled again and reacted in a conditioning cabinet set at 23% RH and 90 0 °C for five minutes.

After that treatment the tow was washed in a solution containing 55% industrial alcohol, 42% water and 3% acetic acid. The washed tow was then treated with a finish containing 99% industrial alcohol and 1% Atlas 61086 emulsifier. The tow was dried at low temperature, leaving some residual moisture on the fibres. The finished tow was WO 95/19795 PCTGB95/00114 cut into fibres.

The fibres had a degree of substitution above 0.i1, a tenacity of 22.5 cN/tex and an extensibility of 12%. The free swell absorbency of the fibres was measured by the free swell absobancy method by dispersing 0.5g fibre in of 0.9% saline solution and leaving for 5 minutes.

The dispersion was then filtered through a sintered Mark 1 funnel of pore size 100-160 microns and was left for minutes, or until it stopped dripping. The water filtered through the funnel was weighed and the weight of water absorbed by the fibres calculated by subtraction. The absorbency was 20% by weight of gel-forming fibres produced according to the above method were carded in a blend with 80% multilimbed regenerated cellulose fibres (Galaxy) to form a web of size 10cm X 10cm. The carded web was then sealed in a foil envelope and sterilized to form a wound dressing.

The wound dressing when in contact with a wound will absorb exudate causing the gel forming fibres to swell and form a gel. The gel will render the wound dressing sufficiently slippery to prevent adherence of the dressing to the newly forming tissue.

Examples Gel forming fibres were produced as follows: A tow of never-dried Tencel fibres of filament decitex 1.7 was padded with a solution of sodium hydroxide and sodium monochloroacetate. The concentrations of the reagents differed as shown in the table below. The tow was lightly mangled to stop dripping and dried at 90 0 C to a moisture level of 13% The resulting tow was washed in a solution containing ethanol, 42% water, 2.5% acetic acid and 0.5% citric acid.

WO 95/19795 PCT/GB95/00114 The washed tow was treated with a finish and dried as described in Example 1.

Example Concentrations Degree of Free Swell No. of Reagents substit- Absorbency Na OH C1CH2 COONa ution g/g 2 4.5 13.3 0.235 3 5.5 16.2 0.29 18 4 6.5 19.2 0.375 28 7.5 22.1 0.405 38 The tow of filaments produced in each example above was cut into 50 mm lengths and 50% by weight of the gel-forming fibres was carded in a blend with 50% viscose rayon fibre (Galaxy) to form a non-woven fabric. The fabric was then sealed in a foil envelope and sterilized to form a wound dressing.

6A Throughout the description and claims of this specification, the word "comprise" and variations of the word, such as "comprising" and "comprises", is not intended to exclude other additives, components, integers or steps.

**4 C\WINWORDUANEL.aSPEC\16673 DOC ~R L1 I

Claims (15)

1. A non-adherent wound dressing in sheet form for use in direct contact with a wound comprising from 50% by weight to 95% by weight of textile fibres mixed with from 5% by weight to 50% by weight of gel forming fibres.
2. A wound dressing as claimed in claim 1 comprising from 75% to 90% by weight of textile fibres and 10% to 25% by weight of gel forming fibres.
3. A wound dressing as claimed in claim 1 comprising from 80% to 95% by weight of textile fibres and 5% to 20% by weight of gel forming fibres.
4. A wound dressing as claimed in any preceding claim wherein the textile fibres are cellulosic fibres.
5. A wound dressing as claimed in any preceding claim wherein the gel forming fibres are chemically modified cellulosic fibres.
6. A wound dressing as claimed in any one of claims 1 to 4 wherein the gel forming fibres are alginate fibres.
7. A wound dressing as claimed in any preceding claim wherein the gel forming fibres have an absorbency of at least 2 g/g. 25
8. A wound dressing as claimed in claim 5 wherein the chemically modified cellulosic fibres have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit.
9. A wound dressing as claimed in any preceding claim wherein the fibres are in the form of a carded web.
C:\WINWORDUANELLESPECI\16673.DOC 8 A wound dressing as claimed in any preceding claim wherein the fibres are in the form of a woven fabric.
11. A wound dressing as claimed in any preceding claim wherein the fibres are in the form of a knitted stocking.
12. Use of a wound dressing as claimed in any preceding claim for the treatment of a wound by placing the dressing in direct contact with the wound.
13. Use of a mixture of fibres comprising from 50% by weight to 95% by weight of textile fibres and 5% by weight to 50% by weight of gel forming fibres in the manufacture of a medicament for use in the treatment of wounds.
14. Use of mixture of fibres comprising from 50% by weight to 95% by weight 15 of textile fibres and 5% by weight to 50% by weight of gel forming fibres in the manufacture of a medicament for use in the treatment of chronic wounds.
15. A wound dressing substantially as hereinbefore described with reference to any one of the examples. DATED: 27 February, 1998 PHILLIPS ORMONDE FITZPATRICK Attorneys for: BRISTOL-MYERS SQUIBB COMPANY 25 BRISTOL-MYERS SQUIBB COMPANY C\WINWORDUANEU.ESPECI16673.DOC I I INTERNATIONAL SEARCH REPORT Int lonal Application No PCT/GB 95/00114 A. CLASSIFICATION OF SUBJECT MATTER IPC 6 A61L15/28 A61L15/60 According to International Patent Classification (IPC) or to both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classificaton system followed by classification symbols) IPC 6 A61L Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted dunng the ntemational search (name of data base and, where practical, search terms used) C. DOCUMENTS CONSIDERED TO BE RELEVANT Category" Citation of document, with indication, where appropnate, of the relevant passages Relevant to claim No. X EP,A,O 344 913 (MINNESOTA MINING MFG) 6 1-14 December 1989 see page 4, line 43 line 47; claims X WO,A,93 11803 (M U R S T) 24 June 1993 1-14 see page 5, line 6 line 28; claims X GB,A,1 207 352 (DAVID TORR) 30 September 1-14 1970 see claims X GB,A,2 221 620 (JOHNSON JOHNSON PATIENT CARE) 14 February 1990 see page 3, line 12 line 18 see page 5, line 19 line 33; claims; examples Further documents are listed in the continuation of box C. j Patent family members are listed in annex. Speaal categones of cted documents Specl categories of cd documenT later document published after the international filing date Sd d t g s or priority date and not in conflict with the application but A document defining the general state of the art which is not cited to understand the principle or theory underlying the considered to be of particular relevance invention E' earlier document but published on or after the international document of particular relevance; the claimed invention filing date cannot be considered novel or cannot be considered to document which may throw doubts on priority claim(s) or involve an inventive step when the document is taken alone which is cited to establish the publication date of another document of particular relevance; the claimed invention citation or other special reason (as specified) cannot be considered to involve an inventive step when the document referrng to an oral disclosure, use, exhibition or document is combined with one or more other such docu- other means ments, such combinaton being obvious to a person skilled document published prior to the international filing date but in the art. later than the priority date claimed document member of the same patent family Date of the actual completon of the international search Date of mailing of the internatonal search report 29 May 1995 0 9. 06 Name and mailing address of the ISA Authonzed officer European Patent Office, P.B. 5818 Patentlaan 2 NL 2280 HV Ri3swilk Tel. (+31-70) 340-2040, Tx. 31 651 epo n ESPINOSA, M Fax: (+31-70) 340-3016 E NO M Form PCT/ISA/210 (second sheet) (July 1992) page 1 of 2 INTERNATIONAL SEARCH REPORT nt. ional Application No PCT/GB 95/00114 C.(Continuauon) DOCUMENTS CONSIDERED TO B31 RELEVANT Category Citation of document, with indication, whcre appropriate, of the relevant passages Relevant to claim No. GB,A,2 062 652 (CHEMIEFASER LENZING INC) 28 May 1981 see claims; examples US,A,4 063 558 (SMITH FREDERICK R) 20 December 1977 see claims 11 295 (RIEGEL TEXTILE CORP.) 31 July 1969 see claims EP,A,0 075 791 (LEIPZIG ARZNEIMITTEL) 6 April W93 see clairh,,; examples 1-4 1-14 F..r PCT/ISA/2l 0 (continuation~ of second shieet) (July 1992) page 2 of 2 INTERNATIONAL SEARCH MEORT In ional Applitation No Inrormvaton on patent tamily membher I P CT/GB 95/00114 Patent document Publication IPatent family Publication ciwcd in search report date Jmember(s) EP-A-0344913 06-12-89 AU-B- 651900 04-08-94 AU-A- 1966592 17-09-92 AU-B- 630092 22-10-92 AU-A- 3397989 07-12-89 CA-A- 1333552 20-12-94 JP-A- 2026559 29-01-90 US-A- 5197945 30-03-93 WO-A-9311803 24-06-93 AU-B- 3346693 19-07-93 EP-A- 0618817 12-10-94 Fl-A- 942894 18-08-94 JP-T- 7502430 16-03-95 NO-A- 942330 17-08-94 GB-A-1207352 30-09-70 FR-A- 1541261 GB-A-2221620 14-02-90 AU-B- 634164 18-02-93 AU-A- 3897389 01-02-90 JP-A- 3009761 17-01-91 NL-A- 8901936 16-02-90 GB-A-2062652 28-05-81 AT-A- 363578 10-08-81 DE-A- 3036415 30-04-81 FR-A,B 2467895 30-04-81 US-A-4063558 2G-12-77 BE-A- 874112 29-05-79 US-E- RE3 1380 13-09-83 US-A- 4199367 22-04-80 DE-A-1511295 31-07-69 BE-A- 687251 22-03-67 CH-A- 439207 FR-A- 1495137 18-12-67 GB-A- 1157003 02-07-69 LU-A- 52041 28-03-67 NL-A- 6613069 19-02-68 EP-A-0075791 06-04-83 SU-A- 1512987 07-10-89 US-A- 4599209 08-07-86 US-A- 4664105 12-05-87 JP-C- 1354483 24-12-86 rorm PCT/tSA/21 0 (patent farnfly Annex) (July 1992) page 1 of 2 rr~ 0 1 INTE RNATIONAL SEARCH REPORT InforMALiOfi on palCnt fAmity members Inw ional Application No PCT/GB 95/00114 Patent document I Publication IPatent family bi cto cited In seaurch report I date Imember(s) I dal EP-A-0075791 JP-A- JP-B- sU-A- 58094851 06-06-83 610229 03-06-86 14178io 23-0888 rorm PCT/ISN/210 (patent family annex) (July 1992) page 2 of 2
AU16673/95A 1994-01-20 1995-01-20 Wound dressing Expired AU691245B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
GB9400994A GB9400994D0 (en) 1994-01-20 1994-01-20 Wound dressing
GB9400994 1994-01-20
PCT/GB1995/000114 WO1995019795A1 (en) 1994-01-20 1995-01-20 Wound dressing

Publications (2)

Publication Number Publication Date
AU1667395A AU1667395A (en) 1995-08-08
AU691245B2 true AU691245B2 (en) 1998-05-14

Family

ID=10749032

Family Applications (1)

Application Number Title Priority Date Filing Date
AU16673/95A Expired AU691245B2 (en) 1994-01-20 1995-01-20 Wound dressing

Country Status (16)

Country Link
US (1) US6471982B1 (en)
EP (1) EP0740554B1 (en)
JP (1) JPH09509590A (en)
AT (1) AT235925T (en)
AU (1) AU691245B2 (en)
CA (1) CA2179415C (en)
DE (2) DE69530180D1 (en)
DK (1) DK0740554T3 (en)
ES (1) ES2193190T3 (en)
FI (1) FI115608B (en)
GB (1) GB9400994D0 (en)
MX (1) MX9602543A (en)
NO (1) NO310059B1 (en)
NZ (1) NZ279516A (en)
PT (1) PT740554E (en)
WO (1) WO1995019795A1 (en)

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